SmartSite MV0400Recalls & reported problems
Yukon Medical, LLC · Carefusion Universal SmartSite Vented Vial Access Device · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403221644), received between Feb 2, 2022 and Feb 2, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Component” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 2, 2022Defective Component; Defective Component
IT WAS REPORTED THAT AT LEAST ONE BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN USING 1ML VIALS FOR BENADRYL AND FENTANYL, THE MV0400 UNIVERSAL VIAL ACCESS DEVICE HAS REPEATEDLY FAILED TO PIERCE THE SEPTUM AND THE ENTIRE SEPTUM IS PUSHED INTO THE DRUG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13426582 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.